Department of Medical Oncology, University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT06367751
The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.
Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).
Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Liquid biopsies, in particular the analysis of circulating tumor DNA (ctDNA), have emerged as a promising tool for detecting and monitoring cancer. Measuring ctDNA in patients with solid malignancies may help to identify targetable alterations, measure disease burden, identify early mutations of resistance, tailor and deescalate cancer treatment, and predict patient prognosis. Although the adoption and application of ctDNA measurements for patients with solid tumors in routine clinical care is increasing, evidence supporting the integration of ctDNA into current practice is limited, especially for patients with advanced cancers.
This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease.
This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes, including quality of life and survival. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent.
Results from ctDNA analyses will be discussed at the molecular tumor board, an established regular interdisciplinary meeting at the University Hospital Basel (part of routine care) to discuss patients with complex findings from tumor sequencing analyses. Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patient's preference as is routine standard of care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
● Patients with primary brain tumors
Blood samples are collected as part of standard of care and ctDNA measurements will be performed on these samples.
Time frame: 1 time assessment at baseline
Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment. Calculated as the number of patients with detectable ctDNA over the total number of patients included, expressed as a percentage.
Time frame: baseline, between month 2 and 3, between month 5 and 6, clinical event
Patients in whom actionable alterations were identified in ctDNA analysis. Calculated as the number of patients with actionable alterations over the total number of patients included, expressed as a percentage.
Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.
Time frame: baseline, between month 2 and 3, between month 5 and 6, clinical event
Time from ctDNA request until issuing the first report. Expressed as hours.
Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.
Time frame: up to 24 months
Change in allelic frequency over time including relative changes from baseline.
Time frame: up to 24 months
Number of ctDNA testing results that were successfully made available to the molecular tumor board.
Time frame: up to 24 months
Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential
Time frame: month 3, month 6, month 12
Global quality of life and physical function as measured by EORTC QLQ C30 and C15 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire). Calculation of the scores follows the validated formulas as issued by the EORTC. Scores range from 0% to 100% for all domains with higher values representing better outcome.
Time frame: up to 24 months
Overall survival.
Time frame: Month 6
Survival rate 6 months.
Time frame: Month 12
Survival rate 12 months.
Time frame: up to 24 months
Time to next treatment line, expressed in days.
Time frame: up to 24 months
Number and proportion of unplanned hospital admissions and emergency room visits.
Time frame: up to 24 months
Progression free survival as determined by routine imaging (e.g. CT scan, MRI), tumor marker (e.g. PSA). Defined as time from date of informed consent until disease progression or death, whatever occurs first.
Time frame: up to 24 months
Number of ctDNA analyses with a valid result - that is all ctDNA analyses conducted without any observed technical errors.
Time frame: up to 24 months
Number and proportion of patients being referred and recruited to a different interventional clinical trial.
Time frame: up to 24 months
Number of (solid) tissue biopsies per patient and proportion of patients receiving a biopsy.
Time frame: up to 24 months
Number of imaging per patient (CT, PET/CT or MRI).
Time frame: up to 24 months
Number of blood products per patient.
Time frame: up to 24 months
Cumulative doses of cancer drug treatments administered.
University Hospital, Basel, Switzerland
Other
Acronym: LIQPLAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06577194
Advanced Solid Tumor, Colorectal Neoplasms
Nanjing, Jiangsu, China
View Trial DetailsNCT06244485
Advanced Solid Tumor
Irvine, California, United States
View Trial DetailsNCT06607185
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06533059
Adnexal Diseases, Advanced Solid Tumor
La Jolla, California, United States
View Trial Details